Injections into the eye (drug Lucentis) in diabetic patients in whom no further treatment is currently available in clinic when they have developed swelling of the centre of the macula associated with lack of blood supply.

Phase 1

• Conditions: Ischaemic Diabetic Macular Oedema; MedDRA version: 14.1Level: LLTClassification code 10057915Term: Diabetic macular oedemaSystem Organ Class: 10015919 - Eye disorders; MedDRA version: 14.1Level: PTClassification code 10012689Term: Diabetic retinopathySystem Organ Class: 10015919 - Eye disorders; MedDRA version: 14.1Level: PTClassification code 10012688Term: Diabetic retinal oedemaSystem Organ Class: 10015919 - Eye disorders; MedDRA version: 14.1Level: LLTClassification code 10057934Term: Diabetic macular edemaSystem Organ Class: 10015919 - Eye disorders; MedDRA version: 14.1Level: LLTClassification code 10054372Term: Diabetic retinal edemaSystem Organ Class: 10015919 - Eye disorders; MedDRA version: 14.1Level: LLTClassification code 10054109Term: Non-proliferative diabetic retinopathySystem Organ Class: 10015919 - Eye disorders; MedDRA version: 14.1Level: PTClassification code 10012661Term: Diabetic eye diseaseSystem Organ Class: 10015919 - Eye disorders; MedDRA version: 14.1Level: LLTClassification code 10038925Term: Retinopathy diabeticSystem Organ Class: 10015919 - Eye disorders; MedDRA version: 14.1Level: HLGTClassification code 10012653Term: Diabetic complicationsSystem Organ Class: 10014698 - Endocrine disorders

• Registration Number: EUCTR2013-000031-27-GB
• Lead Sponsor: Moorfields Eye Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02-15
• Last Update Posted: 3 April 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

•Age >= 18 years
•Diagnosis of diabetes mellitus (type 1 or type 2)
•Best corrected ETDRS visual acuity letter score at 4 metres (and approximate Snellen equivalent), between 20 and 70 letters (6/12 – 3/60)
•Centre-involving diabetic macular oedema
•Central macular thickness (CMT) = 300 µm on Spectralis SD-OCT
•Enlarged foveal avascular zone (FAZ greatest linear dimension (GLD) =1000 µm) or a non-intact perifoveal capillary ring at the margin of the FAZ with FAZ GLD 700-1000 µm

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 70
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

•Blood pressure > 180/110 (systolic above 180 and diastolic above 110).
•anti-VEGF treatment to the study eye within 4 months.
•prior ocular surgery (including vitrectomy, cataract extraction) within 4 months.
•history of treatment for DME at any time in the past 4 months (such as focal/grid macular photocoagulation, intravitreal or peribulbar corticosteroids, anti-VEGF drugs, or any other treatment).
•history of panretinal photocoagulation (PRP) within 4 months or anticipated need for PRP in the 6 months following randomization.
•aphakia.
•Intraocular pressure >25 mmHg.
•conditions/circumstances that preclude/significantly reduce the likelihood of response to therapy e.g. macular atrophy or exudative plaque.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified